Persons with high blood glucose and lipid levels
Conditions
Interventions
Intervention type:BEHAVIOUR
Name of intervention:Allulose,Allulose
Dose form / Japanese Medical Device Nomenclature:SYRUP,SYRUP
Route of administration / Site of application:ORAL,ORAL
Dose per adminis
Sponsors
Matsutani Chemical Industry Co., Ltd.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: (1)Males and females aged 20 to 64 years old (2)Subjects with high normal blood glucose ~ borderline diabetic and high LDL-C (3)Subjects with insulin resistance calculator(HOMA-IR) and over 2.5, and high LDL-C (4)Subjects with high LDL-C (5)Subjects who can come to designated institution on scheduled date of test (6)Subjects who can make self-judgment and are voluntarily giving written informed consent. -High normal blood glucose ~ borderline diabetic: fasting blood glucose levels from 100mg/dl and below 126mg/dl, or HbA1c(NGSP) levels from 6.0% and below 6.5%. -High LDL-C: LDL-C levels from 120mg/dl and below 160mg/dl. -Number of subjects: as a rule, (2)+(3)=45, (4)=45.
Exclusion criteria
Exclusion criteria: (1) These prescreened medicine. (2) Subjects who constantly take oral medicines, functional foods and/or supplements that have a possibility to affect blood glucose levels and lipid. (3) Females who are pregnant or lactating, and females who have possibility of pregnancy. (4) Subjects who donated blood and/or blood components more than 200 mL within 4 weeks prior to the test. (5) Males who donated blood and/or blood components more than 400 ml within 12 weeks prior to the test. (6) Females who donated blood and/or blood components more than 400 ml within 16 weeks prior to the test. (7) Males who were collected blood and blood components more than 1200 ml within 12 months prior to the test when planned blood sampling amount of this test is added. (8) Females who were collected blood and blood components more than 800 ml within 12 months prior to the test when planned blood sampling amount of this test is added. (9) Subjects who are participating in other clinical tests, and/or subjects who participated in other clinical tests within 4 weeks prior to the test. (10) Subjects who consume excessive amount of alcohol or smoke heavily (more than 21 cigarettes a day). (11) Subjects who have extremely irregular dining habits, and/or subjects who work midnight or irregular shifts. (12) Subjects who falls under any of the following criteria. (a) Subjects who have heart disease, liver disease, or kidney disease (including the complication of other diseases). (b) Subjects who have medical history of cardiovascular diseases. (c) Subjects who have diabetes (d) Subjects who are allergic to the test foods (13) Subjects who are judged as unsuitable for this study by principal investigator or sub-investigator.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| (1)Efficacy: body weight, HbA1c (2)Safety: LDL-C, HDL-C | — |
Secondary
| Measure | Time frame |
|---|---|
| (1)Efficacy: visceral fat area, OGTT(AUC) (2)Safety: lipoprotein fractions, carotid artery | — |
Countries
Japan
Contacts
Public ContactNoriko Hayashi
Matsutani Chemical Industry Co., Ltd.
Outcome results
None listed